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510(k) K102831

RSI 4200 by Reimers Systems, Inc. — Product Code CBF

K102831 is an FDA 510(k) premarket notification submitted by Reimers Systems, Inc. for the device "RSI 4200". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Reimers Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
September 29, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

Other clearances by Reimers Systems, Inc.

  • K962869 — GSP1 - GAS SELECTION PANEL (October 23, 1996)
  • K962871 — ODS1 - HOOD DRIVER (October 23, 1996)
  • K954387 — T CLASS HYPERBARIC FACILITIES (December 15, 1995)
  • K951125 — LIFEFORCE CLINICAL HYPERBARIC FACILITY (June 2, 1995)

Other clearances for product code CBF

  • K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (November 21, 2024)
  • K220290 — Revitalair 430+ (May 4, 2023)
  • K171899 — Revitalair 430F (November 22, 2019)
  • K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family (March 22, 2017)
  • K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen (April 29, 2016)
  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (August 13, 2010)
  • K101262 — FLEXI-LITE (June 10, 2010)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (May 22, 2009)

FDA data resources